FDA Fast-Tracks Revolutionary Blood Test: Quest Diagnostics

Quest Diagnostics (NYSE:DGX) has received FDA Breakthrough Device Designation for its Haystack MRD® test, designed to identify minimal residual disease (MRD) in stage II colorectal cancer patients after surgery. The test helps determine which patients might benefit from adjuvant therapy.

The designation follows Quest's launch of a clinical laboratory-developed version of Haystack MRD in late 2024. The test utilizes circulating tumor DNA (ctDNA) technology to detect residual or recurrent cancer from solid tumors. The Breakthrough Device Program aims to accelerate development and review of medical devices for life-threatening conditions while maintaining FDA safety standards.

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